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This pilot study was not powered for analysis of a specific parameter. All patients' data were employed in an intent-to-treat fashion. For the efficacy analysis, the one-sample Student t test was used to compare mean changes from baseline in body weight, BMI, and body composition at each interim evaluation at p = level. The one-sample Student t test was also used to compare increases in respiratory muscle strength, endurance and overall functional capacity, and changes in QOL measures. All p values < were considered statistically significant.

The respective effects on HRWL of megestrol acetate therapy and oxandrolone therapy as compared with the effects of placebo have been shown previously and are similar to those observed here [ 7 , 18 , 27 , 28 ]. Although we did not find significant differences in body weight change between the 2 arms, we observed interesting nonsignificant trends with regard to increases in fat and LBM. As expected (given the respective modes of action of each agent), there was a greater increase in LBM in the oxandrolone group than in the megestrol acetate group, and the reverse was seen with regard to increases in fat. Other possible explanations for the weight gain include a possibly associated reduction in virus load or an increase in CD4 cell count. We examined these parameters and found that both had not changed significantly during the course of the study. The use of testosterone among some male patients may be construed as a potential source of interference with the outcomes. However, all of these patients were hypogonal and were receiving replacement therapy to achieve eugonadal status.

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